Smoking is an addictive habit which has been determined to be a contributory or causative factor in a number of diseases including respiratory diseases such as emphysema, chronic bronchitis, lung infections and lung cancer, but also in various cardiac pathologies. With an increased public awareness of the deleterious effects of smoking on human health, came an increase in the numbers of smokers trying to quit the habit. It is now largely accepted in the scientific and medical community that the nicotine in cigarette smoke creates addiction through the effects it has on brain nicotine receptors. Most regular smokers become addicted to, or dependent upon, the pharmacological effects of nicotine in tobacco smoke. A common strategy in overcoming nicotine addiction in general, and nicotine cravings in particular, is the mimicking of cigarette smoking's effects, followed by gradual reduction and, eventually, by complete elimination.
There are several effects of smoking which a potential therapeutic formulation or method would seek to mimic. Among the most important effects of smoking are the chemical and mechanical impact of cigarette smoke on the airways of the smoker, and the absorption of nicotine into the smoker's blood. The chemical and mechanical impact of cigarette smoke on the airways of the smoker results in a certain level of satisfaction experienced by the smoker. The absorption of nicotine into the smoker's blood results in nicotine reaching various receptors in the nervous system of the smoker, which in turn affects the perceived nicotine cravings experienced by the smoker. Both effects can potentially be mimicked by the administration of nicotine formulations doses to a subject seeking smoking cessation therapy. By gradually reducing the doses, until complete elimination, nicotine addiction can be treated.
Leucine is an amino acid having an aliphatic isobutyl side chain. As a result, leucine is typically classified as a hydrophobic amino acid. Leucine is an essential amino acid because the human body cannot synthesize it and it must be provided from extraneous sources. Leucine has various metabolic roles, and participates, inter alia, to the formation of sterols and to the stimulation of muscle protein synthesis. Lysine is a basic amino acid with an amine side chain. Lysine is an also an essential amino acid that is important for calcium absorption. The terminal amine of lysine can be chemically modified. Glycine, which has no side chain, is the smallest amino acid. Glycine is important for the biosynthesis of the structural protein collagen and has also been employed as a sweetener.
Lactose is a disaccharide found in milk, having two residues: a galactose and a glucose. Lactose is used in pharmaceutical applications, for example as a filler, due to its physical properties (e.g., compressibility). Tartaric acid is a diprotic acid, occurring naturally in many plants, for example grapes and bananas. Tartrates are salts of tartaric acid with basic compounds, such as nicotine. Phospholipids are the major components of cell membranes due to their amphiphilic nature. Phospholipids are also natural components of lung surfactant and are found in high concentrations in egg yolk and cows' milk.
Menthol is a known and widely used topical analgesic, decongestant, and cough suppressant. Almost all cigarettes contain menthol in order to adjust flavoring and reduce coughing. When the menthol concentration in cigarettes exceeds 3%, then it is labeled as a menthol cigarette. Methods of using menthol in cigarettes include addition to the tobacco leaf. A plastic ball filled with menthol can be stored in the filter of a cigarette, and then crushed prior to smoking the cigarette. Upon lighting up the cigarette, the heated smoke acts to volatilize and carry the menthol into the airways of the smoker.
There is a need in the art for improved formulations of nicotine, especially dry powder formulations suitable for inhalation. The present invention meets this need.